FDA product code KID: Restraint, Wheelchair, Non-Protective

KID is the FDA product code for restraint, wheelchair, non-protective. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel. FDA has cleared 7 510(k) submissions under KID, from 3 different applicants. The average 510(k) review took 80 days (median 42).

Classification

FieldValue
Device nameRestraint, Wheelchair, Non-Protective
Device classClass I
Regulation21 CFR 890.3910
Review panelPM — Physical Medicine
Medical specialtyPhysical Medicine
Premarket route510(k) exempt
GMP exemptYes

Compare with all 510(k) review times · Search every KID clearance

Top KID applicants

ApplicantClearancesLatest
Deroyal Industries, Inc.31997-01-24
Skil-Care Corp.31996-10-15
Jefferson Industries, Inc.11980-11-12

Most recent KID clearances

510(k)ApplicantDeviceDecision dateReview days
K963479Deroyal Industries, Inc.WHEELCHAIR BELT1997-01-24143
K963480Deroyal Industries, Inc.MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER1997-01-22141
K963475Deroyal Industries, Inc.PONCHO VEST RESTRAINT1997-01-22141
K963459Skil-Care Corp.SUPPORT VEST1996-10-1542
K963461Skil-Care Corp.SAFETY PONCHO/SHOULDER STRAP PONCHO1996-10-1138

Recalls for KID devices

openFDA lists no recalls for product code KID.

Frequently asked questions

What is FDA product code KID?

KID is the FDA product code for restraint, wheelchair, non-protective. It is a Class I device, regulated under 21 CFR 890.3910 and reviewed by the Physical Medicine panel.

What device class is KID?

Class I, regulation 21 CFR 890.3910. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code KID?

Across 7 cleared submissions the average was 80 days from receipt to decision (median 42).

Which companies have the most KID clearances?

Deroyal Industries, Inc. (3); Skil-Care Corp. (3); Jefferson Industries, Inc. (1).

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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